One's sexual functioning is not only an expression of reproductive capacity and gender identity but also serves a major role in cementing the emotional bond with primary partner. When this capacity is diminished or disrupted, the psychological implications can range from minor to catastrophic, depending upon the individual history & situation. Therefore treatment of sexual dysfunction is imperative as it can have a profound effect on the well-being of the individual.
Thus, sexual dysfunction has considerable importance and form the subject of intensive biomedical research efforts. According to recent statistics, the problem of impotence in its various forms (such as absence or loss of libido, erectile dysfunction and premature ejaculation) affects some 70% w/w of the population aged approximately 50 and over.
Male sexual dysfunction can be caused by physical or psychological stress. Sexual dysfunction may be of any one of following type:                Loss of libido        Erectile dysfunction        Premature ejaculation        Delayed or inhibited orgasm        Physical abnormalities of the penis        
Treatment for Male Sexual Dysfunction:
Male sexual dysfunction is generally the combination of one or more of above mentioned symptoms. Thus the approach of the therapy should be to treat all the symptoms simultaneously, till today most of the available measures aim to target only one or two aspects of sexual dysfunction and not to improve overall sexual life.
Various aspects of treatments have been suggested for male sexual dysfunction associated disorders as exemplified below.                Depression or anxiety disorders may need treatment.        Any physical problems that may be affecting sexual function should be addressed.        If a medication is interfering with sexual function, it may be possible to change or discontinue the medication.        Prescription medications that treat erectile dysfunction may help a man to achieve and maintain erections.        Hormonal treatment, such as testosterone replacement therapy, may help with hormone imbalances that are contributing to sexual dysfunction.        For psychological causes of sexual dysfunction, such as relationship problems may be treated beneficially by counseling, either individually or as a couple.        Sexual therapy with a therapist who specializes in sexual dysfunction may also help to resolve the problems.        In obese men with erectile dysfunction, weight loss and increased physical activity are associated with an improvement in erectile function in about one third of patients        
Therapy of men with erectile dysfunction is aimed at restoration of the two vital sexual functions: the capacity to acquire and sustain penile erections; and the reactivation of libido. Optimal treatment varies with the cause of the erectile dysfunction (Tables 2A-2B): Phosphodiesterase-5 (PDE-5) inhibitors, penile self-injection programs with vasoactive drugs, vacuum erection devices, or penile prostheses allow many men with vasculogenic, neurogenic, or psychogenic erectile dysfunction to acquire and maintain erections.
Oral treatments for male sexual dysfunction (Table 2 A)MedicationMechanismPros and consDosingSildenafilInhibits enzyme100 mg effective in 75Taken one hour(Viagra ®)phosphodiesterase 5,percent of men.before sex andallowing cyclic GMPSide effects: headaches,effective up toto accumulate withindyspepsia, vasodilation,four hours.penisdiarrhea and blue tinge toStimulationvision.needed forContraindicated if usingerection.nitrates.Dose: 25 to 100 mgVardenafilSame as sildenafilSimilar efficacy/side effectsSimilar onset and(Levitra)to sildenafil, but no visualduration of actionside effects.as sildenafil.Dose: 2.5 to 20 mgTadalafilSame as sildenafilsSimilar efficacy/side effectsSimilar onset of(Cialis)to sildenafil, but no visualaction as sildenafil.side effects.Duration of actionis up to 36 hours.Dose: 2.5 to 20 mgYohimbineBlocks presynapticUsed for psychogenic ED.5.4 mg TIDalpha-2 receptors.May have placebo effect.Stimulates mid-brain,Alternative to testosteroneincreases libido.for libido.Might increase localAnxiety and insomnia areblood flow, decreasesside effects.outflow.May increase labilehypertension.TrazodoneAlpha blockerUsed for psychogenic ED.50-100 mg/daycomponent.Treats depression.May cause priapism.Dizziness, lethargy are sideeffects.
Suppositories, injections, and devices for sexual dysfunction (Table 2B)TreatmentEffectPros and consUsage patternSuppository-Alprostadil (prostaglandinCan be used twiceInserted 5-10MUSE (alprostadil)E1) in gel form delivereddaily. Notminutes before sex.by applicator into meatusrecommended withEffects last 1 hour.of penis.pregnant partners.AlprostadilProstaglandin E1 injectedEffective in 50 to 85Inject 10-20 minutes(Caverject andinto base of penis. Causespercent of cases.before sex.Edex)smooth muscle relaxationMay be painful andErections may lastin corpus cavernosae.not recommendedover an hour.for daily use.Priapism occursuncommonly.Invicorp (VIP andPeptide, VIP and alpha-Possibly moreInject 10-20 minutesphentolamine)blocker, phentolamineeffective thanbefore sex. Requirescauses relaxation of penilealprostadil. Causesstimulation to havevascular smooth muscle.less pain. Priapismerection.rare.Device-VacuumRemoves air fromOne-time expense.Inflated just beforepumpchamber over penis,Safe if erection notsexual activity.creating a vacuum andmaintained moreErection lasts untildrawing blood into penilethan one hour. Mayelastic ring removed.cavernosae. Elasticnot be acceptable totourniquet at base holdspartner. Penis isblood in penis.hinged at base. Mayinterfere withejaculation.
Recently, research has been done on Erectile Dysfunction and Sildenafil has been made available for patients, but it has shown to provide benefit only to patients with Erectile Dysfunction but not for other parameters like loss of libido and premature ejaculation. It is also contradicted in patients who are taking nitrates. The adverse events associated with these drugs are sudden decrease or loss of hearing & vision. The most common side effects of these medications are headache, facial flushing, and upset stomach. Less commonly, bluish vision, blurred vision, or sensitivity to light may briefly occur.
US 2003/0152650 discloses pharmaceutical composition for the prevention and treatment of premature ejaculation and/or hypersensitivity of sexual stimulation is provided. The composition contains purified sumsoo extract and purified ginseng extract containing saponin as the main component, without other herbal essential oil components.
US 2006/0269623 teaches about herbal compositions and methods of treatment for prevention or treatment of erectile dysfunction disorders and ameliorating symptoms thereof and as a preventative measure against erectile dysfunction. The methods comprise administering a therapeutically effective composition of matter comprising the following herbal and other components: Herba cynomorii, Rhizhomnas atractylodis macrocephalae, Radix rehmannia glutinosea longui, Herba epimedii, Fructus lycii, Fructus schisandrae chinensis, Radix poloygoni multiflor, Cortex cinnamonia cassiae, Fructus amoni, and Radix ginseng.
WO 03/094944 discloses a pharmaceutical composition which are useful in the treatment of male and female sexual dysfunction comprising extracts of Tribulis teristris, Epimedium koreanum, Cinnamonon cassia in the weight ratio of 1.5-3.5:1-2:0.1-0.4, respectively; and optionally arginine or a physiologically equivalent ester, salt or precursor thereof and a suitable carrier or excipients. The increase in sexual activity can only be obtained by using the extracts of the various plants with the said precise ratio.
WO 2000/002573 describe about composition and method for treating sexual dysfunction by natural means using a combination of L-arginine, ginseng and Zizyphi fructus in an orally administered dosage. The combination works synergistically to alleviate erectile dysfunction by stimulating enough release of NO in the corpus cavernosum to produce and sustain smooth muscle relaxation, thereby allowing the inflow of blood and alleviating erectile dysfunction. Thus, a natural medicinal alternative to Viagra (Sildenafil) is provided for the treatment of erectile dysfunction. The composition and method is also useful in treating sexual conditions in females.
Various other devices such as vacuum devices, penile implants are available, but benefit only those patients whose function has been severely impaired. Bruising, skin breakdown, and penile pain may occur while using these devices.
It is evident from the prior arts that existing treatments for male sexual dysfunction have side effects or are not very comfortable for usage. These treatments do not show effect on all aspects of Male Sexual Dysfunction. There is therefore a need in the art to provide a product which is safe and treats various aspects of Male Sexual Dysfunction such as erectile dysfunction, quality of erection, premature ejaculation, libido levels, orgasmic function, satisfaction ratings for sexual intercourse and the frequency of sexual intercourse.
Therefore, the instant invention aims to provide synergistic combination of the ingredients derived from natural sources preferably plants and minerals to treat the above aspects of male sexual dysfunction simultaneously without considerable side effects.
Various herbs that can be used for the purpose of the present invention to treat various aspects of sexual dysfunction are described below:
Tribulus terrestris (Gokshur)
Gokshur is a plant-based drug used as an aphrodisiac, a diuretic, and has proven useful in the treatment of urolithiasis, dysurea, impotence, and kidney dysfunction.
Withania somnifera (Ashwagandha)
Ashwagandha has been used for thousands of years as a popular remedy for many conditions. Perhaps its main use, as described in Ayurvedic literature, is as a “rasayana” or rejuvenating drug. The word Ashwagandha indicates the equine (of horses) odor of the plant. Ashwagandha is one of the best known and most researched Ayurvedic herbs and holds a place in the Ayurvedic traditions similar to Ginseng in Chinese therapies. For that reason, Withania somnifera is often referred to as the “Indian Ginseng”. Withania somnifera is used in several indigenous drug preparations for maintaining health as well as treatment of several disease conditions.
Asparagus adscendens (Safed Musali)
Safed Musli is one of the chief ingredients in Ayurveda and other local folklore medicines for ages. The dried roots of Safed Musli (Asparagus adscendens) are used in Unani medicine as an aphrodisiac as they are rich in glycosides. Safed Musli offers significant protection against stress induced changes. It cures many physical illness and weakness and for increasing general body immunity. Safed Musli is used for the preparation of health tonic that is used in general weakness and debility.
Mucuna pruriens (Kawach)
It is considered as one of the most effective aphrodisiac, also used in treatment of liver and gall bladder disorders. Mucuna pruriens seeds have also proven to be effective in profuse menstruation. Kawach is extensively used to treat Parkinsonism and diabetes.
Mucuna pruriens is a widely available Indian herb with seeds having wonderful therapeutic properties. The seeds due to the presence of L-DOPA and nicotine are in great demand. L-DOPA is a neurotransmitter precursor, and is effective for relief in Parkinson's disease. Seeds of Mucuna pruriens are prescribed in the form of powder in the treatment of leucorrhoea, spermatorrhoea, and in cases requiring aphrodisiac action Seed powder including seed coat is an ingredient of the ayurvedic drug Vita-ex given as an aphrodisiac. It is prophylactic against oligospermia and is useful in increasing sperm count, ovulation in women, etc. It prevents male and female sterility and acts as a nervine tonic. Mucuna pruriens seeds are widely used for treating male sexual dysfunction in Unani Medicine, the traditional system of medicine of Indo-Pak sub-continent. Mucuna pruriens seeds are also proven to be effective in profuse menstruation and in paralysis and have been used since ancient times in the treatment of nervous disorders.
Asteracantha longifolia (Gokhulakanta)
This herb is a tonic and stimulant. It promotes libido. The ash of the plant serves as an excellent diuretic. The root of the plant is beneficial in the treatment of gonorrhoea and urinary disorders, including inflammation of the urinary tract and stone in the kidneys. Its decoction can be given in doses of 30 to 60 grams, twice or thrice a day. The decoction of its leaves can be used with confidence in case of syphilis and gonorrhoea. The mucilage obtained by infusing the seeds in water is also prescribed in gonorrhoea, urinary diseases and as a tonic. Chloroform extract of the leaves of Asteracantha longifolia may be used for haematopoietic activity in Ayurvedic system of medicine.
Curculigo orchioides (Kali Musali)
According to references found in Ayurveda, Kali Musali root having property of heating, aphrodisiac, alternative, appetizer, fattening and useful in treatment of piles, biliousness, fatigue, blood related disorders etc.
Asphaltum (Shilajit)
Shilajit has been used historically for general physical strengthening, anti-aging, blood sugar stabilization, libido, injury healing, urinary tract rejuvenation, enhanced brain functioning potency, bone healing, kidney rejuvenation, immune system strengthening, arthritis, hypertension, obesity and many other application for numerous conditions.
Anacylus pyrethrum (Akarkarbh)
This perennial plant, in habit and appearance like the chamomile, has stems that lie on the ground for part of their length, before rising erect.
Root of the Anacyclus pyrethrum is used to treat premature ejaculation. In Ayurvedic literature it is referred as “shukrastambhak dravya”
Piper longum (Pippali)
The botanical name of pippali is Piper longum and it belongs to family piperaceae. The fruits contain 1% volatile oil, resin, a waxy alkaloid, a terpenoid substance and alkaloids piperine and piperlongumine. The roots contain piperine, piperlongumine or piplartine. The seeds contain sylvatin, sesamin and diaeudesmin.
Pippali is a Rasayana plant appearing in ancient medicinal literature reputed in Ayurveda to promote physical and mental health, improve defense mechanisms of the body, and enhance longevity. This herb yields an alkaloid called Piperine. Piperine is a proven bioenhancer that increases the availability of nutritional substances. Pippali as a powerful 4:1 ratio extract stimulates thermogenic response or the release of metabolic heat energy in the body causing a noticeable “warming of the loins” as a precursor to sexual activity.
The individual ingredients discussed above of the present invention have been in use since ancient times for variety of diseases.
Many natural ingredients have been listed in the literature of traditional medicinal systems for their aphrodisiac activity. Such ingredients are available for the management of one or more symptoms of sexual dysfunction. Higher therapeutic dose of single ingredient and lack of selectiveness/effectiveness against various aspects of sexual dysfunction are again of major concerns. Many attempts in the prior art have been made to prepare the combinations of such ingredients as a remedy for overall sexual satisfaction. The drawbacks of the prior art formulations are least standardization, no impurity profiling, pesticide residues (in case if raw material from cultivated herb), variable concentration of actives, unacceptable pharmaceutical dosage form and most importantly, the lack of safety and efficacy background through preclinical and clinical studies.
The existing treatments do not show effect on all aspects of Male Sexual Dysfunction. Therefore, the instant invention provides the synergistic combination of the ingredients derived from natural sources preferably plants and minerals to treat all aspects of male sexual dysfunction simultaneously without considerable side effects. The synergistic composition of the present invention is observed to work effectively against the various sexual dysfunction.
Therefore, the objective of the present invention is to provide synergistic herbal composition useful for the treatment of various aspects of Male Sexual Dysfunction such as erectile dysfunction, loss or decreased libido, and premature ejaculation as well as to improve Male Sexual Function.